Prostate Cancer
Conditions
Keywords
Prostate Cancer, PET, MRI, Hybrid, Recurrence, Fluorocholine
Brief summary
Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy. We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.
Detailed description
The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the attending clinician. Clinical management questionnaires completed by the study investigator will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical decision making.
Interventions
OTHER18F-FCH PET/MRI imaging
Patients will first undergo screening to ensure eligibility. If eligible, they will undergo one scan in a Hybrid PET/MRI scanner using 18F-FCH as the radiolabeled tracer.
Sponsors
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy or radiotherapy * Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months apart and an absolute PSA \> 0.2 ng/mL * Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease
Exclusion criteria
* Evidence of metastatic disease * Contradiction to 18F-FCH PET scan * Contraindication to MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency in change of clinical management based on results of 18F-FCH PET/MRI | Within 2 weeks of study scan | A questionnaire to assess the planned management will be completed by the investigator before and after provision of the results of the 18F-FCH PET/MRI to determine if the information provided by 18F-FCH PET/MRI influences the preferred plan of management |
Secondary
| Measure | Time frame |
|---|---|
| Number of lesions identified with 18F-FCH based on consensus reporting | Within 2 weeks of study scan |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concordance between MRI and 18F-FCH PET for lesion identification | Within 2 weeks of study scan | Lesions identified on the 18F-FCH MRI/PET will be examined to determine what proportion of lesions are present on both MRI and PET imaging versus what proportion of lesions are present on only one of MRI or PET |
Countries
Canada
Outcome results
None listed